Qualifying Multi-Transcript Signatures for Active Surveillance of Prostate Cancer

用于前列腺癌主动监测的合格多转录本签名

基本信息

批准号：
8762344
负责人：
HYUNG L KIM
金额：
$ 60.56万
依托单位：
CEDARS-SINAI MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-02 至 2019-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8762344
关键词：
Address Adverse effects African American Biological Assay Biological Markers Biopsy Biopsy Specimen Cancer Etiology Caucasians Caucasoid Race Cessation of life Clinical Data Data Set Diagnosis Diagnostic Disease Disease Progression Enrollment Ethnic Origin Ethnic group Extracapsular Genes Glare Gleason Grade for Prostate Cancer Goals Guidelines Histologic Laboratories Laboratory Study Leadership Local Therapy Louisiana Malignant Neoplasms Malignant neoplasm of prostate Measurement Medical center Molecular Natural History Needle biopsy procedure Neoplasm Metastasis Newly Diagnosed North Carolina Oligonucleotide Microarrays Oligonucleotides Operative Surgical Procedures Outcome Pathologic Pathology Patients Performance Population Surveillance Positioning Attribute Prostate Prostatectomy Prostatic Neoplasms Public Health Qualifying Quality of life RNA Radiation Radiation therapy Radical Prostatectomy Research Personnel Risk Roswell Park Cancer Institute Sampling Seminal Vesicles Severities Societies Specimen Stratification Testing Time Training Transcript Translating Universities Validation adverse outcome base cancer diagnosis cancer risk cohort computerized data processing density disorder risk ethnic difference high risk improved lymph nodes men outcome forecast performance tests prognostic public health relevance tool transcriptomics

项目摘要

DESCRIPTION (provided by applicant): The vast majority of men diagnosed with prostate cancer do not die of their disease and can choose to delay or avoid surgical or radiation treatment by undergoing active surveillance. Patients diagnosed with prostate cancer that is categorized as low risk are ideal candidates for active surveillance. Unfortunately, clinical and pathologic parameters available at the time of diagnosis will understage or undergrade prostate cancer in approximately 1/3 of all cases. Therefore, better strategies are needed to risk-stratefy newly diagnosed, low risk prostate cancer. The goal of the proposed project is to evaluate existing RNA-based multi-analyte signatures for risk-stratification at the time of prostate cancer diagnosis. To address the glaring absence of well-established criteria for active surveillance in non-Caucasian men, the validation is performed in parallel in separate Caucasian and African-American cohorts. The project consists of an academic-commercial partnership between Cedars-Sinai Medical Center, Johns Hopkins, University of Toronto, Roswell Park Cancer Institute, and GenomDx Biosciences. The consortium will evaluate signatures trained and tested in large numbers of prostatectomies and confirmed to be predictive of adverse prostate cancer pathology and disease progression. It is now clear that majority of patients who have undergone prostatectomy in the past are candidates for active surveillance; therefore, signatures from prostatectomies are likely to be relevant to diagnostic biopsies from modern active surveillance candidates. The specific aims are (1) to validate biomarkers in prostate needle biopsies predictive of adverse pathology and progression in men considering active surveillance and (2) to test the effects of African-American ethnicity on the biomarker signatures. The consortium is well-positioned to rapidly translate and promote validated signatures since all assays will be performed in a CLIA-approved laboratories, and study investigators have leadership positions in cooperative groups, national professional societies, and national guidelines committees.

描述（由申请人提供）：绝大多数被诊断出患有前列腺癌的男性不会死于疾病，可以选择通过进行主动监测来延迟或避免手术或放射治疗。被诊断为被归类为低风险的前列腺癌的患者是主动监测的理想候选者。不幸的是，在诊断时可用的临床和病理参数将在大约1/3的所有情况下进行临床和本科前列腺癌。因此，需要更好的策略来进行风险施加新诊断的低风险前列腺癌。拟议项目的目的是评估在前列腺癌诊断时进行风险分层的现有基于RNA的多分析物特征。为了解决非高加索男性主动监视的明显缺乏，该验证是在单独的高加索和非裔美国人同伙中并行进行的。该项目由Cedars-Sinai医疗中心，Johns Hopkins，Toronto大学，Roswell Park Cancer Institute和GenomDX Biosciences之间的学术商业合作伙伴关系。该财团将评估经过大量前列腺切除术和测试的特征，并确认可以预测前列腺不良癌症病理学和疾病进展。现在很明显，过去大多数接受过前列腺切除术的患者是进行主动监测的候选者。因此，前列腺切除术的特征可能与现代活跃监视候选者的诊断活检有关。（1）在考虑主动监测的男性不良病理学和进展中，在前列腺针头活检中验证生物标志物的具体目的是（2）测试非裔美国人种族对生物标志物特征的影响。该财团的位置很好，可以快速翻译和促进经过验证的签名，因为所有测定法都将在CLIA批准的实验室中进行，并且研究调查人员在合作团体，国家专业社会和国家准则委员会中具有领导地位。